Device and method for maintaining unobstructed nasal passageways after nasal surgery

ABSTRACT

Methods and devices for maintaining nasal passages open after nasal surgery are provided. In some embodiments, the method of the present invention includes initially cleaning at least some of the bodily fluids from the nasal passages of a patient after the nasal surgery; providing a post-operative device having a first tubular member with a first proximal end and a first distal end, and a second tubular member with a second proximal end and a second distal end, where the first proximal end is connected to the second proximal end with a bridging member, and the post-operative device is splintless; inserting the first distal end and the second distal end into the nasal passages of the patient to a location where the first proximal end and the second proximal end each protrude beyond the nostril opening of the patient; and placing a packing material at least partially around each tubular member. In some embodiments of the present invention, a specialized speculum is provided to facilitate placing packing material around the tubular members of the medical device. Medical kits for use following nasal surgery are also provided.

FIELD OF THE INVENTION

The present invention relates generally to medical devices and methods,and more particularly, to medical devices and methods for use afternasal surgery.

BACKGROUND OF THE INVENTION

Nasal surgery may be performed for purposes such as appearanceenhancement, reconstruction following an injury, or breathingimprovement. Following nasal surgery, it is typically necessary to placepacking into the nasal cavity upon the conclusion of the surgery. Suchpacking may be used to temporarily maintain nasal components in theirproper and anatomically correct positions after any manipulation,repositioning, and/or reconstruction that took place during the surgery,while nature begins the healing and repair process.

Nasal packing may also be used following nasal surgery to reduce thechance of bleeding, by prophylactically tamponading the nasal structuresmost likely to be the source of bleeding, such as the interior of thenose which contains a plurality of blood vessels. Bleeding after nasalsurgery can be fatal or result in the loss of a considerable amount ofblood and cause serious complications.

Post-operative nasal packing may be required for up to five days afternasal surgery. For most patients, any pain following the surgery may becontrolled with medication and is secondary to the essentially completenasal obstruction caused by the packing material. The packing makesmouth breathing obligatory and can cause a dry throat and extremediscomfort for the patient. In addition, the patient's sense of smell,which may be critical to the enjoyment of food, may be compromised. Allof this often creates a frightened and anxious patient.

The reported extreme discomfort and the above other significantdissatisfactions caused by the current, requisite full post-operativenasal packing has caused potential patients to forego life-changingnasal surgery that would otherwise have been successful in improvingallergy symptoms, improving smell and taste, preventing significantcomplications such as sinus infections, improving appearance, and/orpreventing snoring, for example. Prior attempts to address such problemsinclude the use of a nasal splint with integral, partial breathingpassages, such as the splint disclosed in U.S. Pat. No. 3,935,859 toDoyle, where the purpose of the splint is to stabilize the repairednasal septum. Such devices do not contain full breathing tubes, nor dothey include breathing tubes that are amenable to easy cleaning by thepatient, as the tubes reside entirely within the nasal passages.Experience has shown that such devices quickly become obstructed and,without proper medical attention, the blockage cannot be relieved.

Prior attempts to maintain open nasal passageways after surgery includeembedding an airway within a pre-formed packing material. Such devicesare limited to use with only the type, size, and configuration ofpacking material supplied with the device and cannot be modified basedupon the preferences of the physician or the patient. Further, suchdevices do not allow for easy cleaning of the airway by the patient andtherefore, cause patient discomfort as a result of obstruction of theairway.

Other attempts have been made to develop devices for insertion into thenasal passages, where the devices are designed to prevent snoring. Suchdevices are not designed for post-operative use. For example, several ofthese devices exert pressure against the inner walls of the nasalpassages, which may be damaging to the delicate nasal architecture aftersurgery. In addition, because such devices are not designed for useafter surgery, they do not address the problem of obstruction caused byaccumulating blood and other bodily fluids following nasal surgery.

Therefore, what is needed are devices and methods that allow theadvantages of complete nasal packing following surgery without totallyobstructing the nasal passages of a patient and compromising thepatient's ability to breathe normally, and without causing damage to thedelicate nasal architecture following nasal surgery.

SUMMARY OF THE INVENTION

In some embodiments of the present invention, a method for maintainingnasal passages open after nasal surgery is provided. The method mayinclude: initially cleaning at least some of the bodily fluids from thenasal passages after nasal surgery; providing a post-operative devicehaving a first tubular member with a first proximal end and a firstdistal end, and a second tubular member with a second proximal end and asecond distal end, where the first proximal end is connected to thesecond proximal end with a bridging member, and the post-operativedevice is splintless; inserting the first distal end and the seconddistal end into the nasal passages of the patient to a location wherethe first proximal end and the second proximal end each protrude beyondthe nostril opening of the patient; and at least partially surroundingeach tubular member with packing material. In some embodiments, prior tothe placement of the packing material, the bridging member is secured tothe columella of the patient using sutures, for example, to preventdisplacement. The first proximal end may be connected to the secondproximal end either before or after the first distal end and the seconddistal end are inserted into the nasal passages. In other embodiments, asingle-unit medical device is used, and no connection is necessary.

In certain embodiments, the method of the present invention includescleaning each tubular member with a fluid-containing syringe, which mayinclude an adapter to removably connect the syringe to each tubularmember. In some embodiments, the method includes measuring the length ofthe nasal floor of a patient and trimming the first distal end and thesecond distal end, based on the result of the measuring, prior tosecuring the post-operative device.

In some embodiments of the present invention, a specialized speculum isprovided to facilitate placing packing material at least partiallyaround the tubular members of a post-operative medical device. Thespeculum may include two leg members, where one leg member includes anengagement member configured to coincide with the tubular member andpermit the medical professional to exert pressure against the tubularmember to thereby increase the space between the tubular member and theinner portion of the nostril and facilitate insertion of packingmaterial into the nasal cavity using forceps or another suitable medicalinstrument.

In other embodiments of the present invention, a medical kit for usefollowing nasal surgery is provided. The medical kit may include apost-operative medical device having a first tubular member with a firstproximal end and a first distal end, and a second tubular member with asecond proximal end and a second distal end, where the first proximalend is connected to the second proximal end with a bridging member, andthe post-operative device is splintless; an insertion speculum adaptedto at least partially surround and mate with the post-operative medicaldevice; and a syringe for cleaning the tubular members of the medicaldevice. The medical kit may also include a packing material and/or ameasuring device configured to measure the length of the nasal floor ofa patient.

Other features and advantages of the present invention will be apparentfrom the following detailed description of exemplary embodiments, takenin conjunction with the accompanying drawings which illustrate, by wayof example, the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of a post-operativemedical device of the present invention;

FIG. 2 is a top view of the post-operative medical device of FIG. 1;

FIG. 3 is a front view of the post-operative medical device of FIG. 1;

FIG. 4 is a perspective view of the post-operative medical device ofFIG. 1 inserted into the nasal passages of a patient;

FIG. 5 is a magnified perspective view of one embodiment of thepost-operative medical device of the present invention inserted into thenasal passages of a patient;

FIG. 5A is a perspective view of one embodiment of the post-operativemedical device of the present invention after the insertion of packingmaterial around the tubular members of the medical device;

FIG. 6 is a sectional view of the nasal architecture of a patientillustrating the placement of a tubular member of one embodiment of apost-operative medical device of the present invention in a nasalpassage of the patient;

FIG. 7 is a perspective view illustrating the use of a device forcleansing a tubular member of one embodiment of a post-operative medicaldevice of the present invention;

FIG. 8 is a perspective view of one embodiment of the specializedspeculum of the present invention;

FIG. 8A is an illustration of one embodiment of the specialized speculumof the present invention inserted into a nostril opening of a patient;and

FIG. 9 is an illustration of the placement of packing material into thenasal cavity of a patient using one embodiment of a specialized speculumof the present invention.

Wherever possible, the same reference numbers will be used throughoutthe drawings to refer to the same or like parts.

DETAILED DESCRIPTION

Referring now to FIGS. 1 to 3, one embodiment of a post-operativemedical device 10 of the present invention is shown. In this embodiment,the medical device 10 is splintless. That is, the medical device isdevoid of splints, where a splint is generally a device that is used tostabilize a repaired nasal septum. Although this embodiment of themedical device of the present invention is splintless and need not beused in conjunction with a splint to achieve its intended purpose, themedical device may, nonetheless, be used in conjunction with a splint,if the medical professional so chooses.

The embodiment of the medical device 10 shown in FIGS. 1 to 3 includestwo tubular members 20, where each tubular member 20 has a plurality ofgraduations 22 and a slight curvature along its length. Each tubularmember 20 has a proximal end 30, a distal end 32, and a lumen 24 thatextends from the proximal end 30 to the distal end 32. The proximal end30 of one tubular member 20 is connected to the proximal end 30 of theother tubular member 20 with a bridging member 26. Any suitable bridgingmember may be used to prevent extrusion of the tubular members from thenasal passages. For example, the bridging member may be a suture or apiece of plastic having any suitable shape.

As shown in FIGS. 1 and 2, the bridging member 26 is placed a distance dfrom the tip 34 of the proximal end 30. In this embodiment, the bridgingmember 26 contains a plurality of apertures 28 through which a suturemay be passed to attach the bridging member 26 to a columella of apatient. In other embodiments, the bridging member is connected to asingle tubular member adapted for insertion into one nasal passage.

Although in the embodiments shown in FIGS. 1 to 3 the tubular members 20have a generally symmetrical, slightly curved, cylindrical configurationwith a generally circular proximal tip 34, numerous other configurationsare possible. For example, in some embodiments of the present invention,the tubular members of the medical device have a generally straightconfiguration with oblong proximal ends. Any tubular memberconfiguration that fits comfortably within the nasal passages of apatient and permits sufficient airflow through the nasal passages may beused.

The medical device 10 may be placed within a patient after nasalsurgery, as shown in FIG. 4. As shown, each tubular member 20 is placedinto the nostril openings 38 of the patient and through the nasalpassages, as shown in more detail in FIG. 5. The bridging member 26 liesbeneath the columella 42 of the patient and may be attached to thecolumella 42 with a suture 40 that passes through one or more apertures28 in the bridging member 26, and the suture may be tied on the externalside of the bridging member 26. In addition, an external nasal protector36 may be applied to the top of a patient's nose following surgery, asshown in FIG. 4. Referring now to FIG. 5A, one embodiment of thepost-operative medical device of the present invention is shown withpacking material 58 placed within the nasal cavity of a patient near thetubular members 20 of the medical device.

The internal positioning of one embodiment of a tubular member 20 of amedical device of the present invention is shown in FIG. 6. As shown,the tubular member 20 protrudes from the nostril opening 38 and extendsinto the nasal cavity 44, lying near the floor 46 of the nasal cavity44. The distal end 32 of the tubular member 20 extends to a positionnear the upper portion of the throat 48 and the back portion of thenasal cavity 50, beyond the area of the nasal cavity that ultimatelywill be filled with packing material. Air flows from the proximal end 30of the tubular member 20 to the distal end 32 of the tubular member 20and, via the throat, into the lungs of the patient.

The embodiments of the medical device of the present invention may haveany suitable dimensions, so long as each tubular member of the medicaldevice fits comfortably within the nasal passage of a patient withoutexerting excessive pressure on the inner walls of the nasal cavity. Insome embodiments, each tubular member has an inner diameter of about 2millimeters to about 6 millimeters and an outer diameter of about 4millimeters to about 8 millimeters. In other embodiments, each tubularmember has an inner diameter of about 3 millimeters to about 5millimeters and an outer diameter of about 5 millimeters to about 7millimeters. In still other embodiments, each tubular member has aninner diameter of about 4 millimeters and an outer diameter of about 6millimeters.

Each tubular member of the medical device of the embodiments of thepresent invention may have any suitable length for positioning within anasal passage of a patient. In certain embodiments, each tubular memberhas a length such that the tubular member protrudes slightly beyond thenostril opening of a patient, as shown in FIGS. 4 and 5, and extendsrearwardly to a location near the back of the nasal cavity, as shown inFIG. 6. In some embodiments, each tubular member is adapted to betrimmed to the appropriate length. The appropriate length may bedetermined by the use of a suitable measuring device, includinggraduated markings on the medical device itself.

Any suitable materials may be used for the medical device of the presentinvention. In some embodiments, a soft and pliable medical grade siliconis used for both the tubular members and the bridging member. In otherembodiments, a more rigid material is used. If desired, any or allportions of the medical device also may include a suitable coating.

In some embodiments of the present invention, the post-operative medicaldevice includes three separate components: a first tubular member, asecond tubular member, and a bridging member, where the components areconnected to one another by one or more suitable connecting mechanisms.In other embodiments, the medical device is a single, integrally moldeddevice. Such an embodiment eliminates the possibility of separation ofthe components during insertion or removal of the device or during theduration of residence of the device within the nasal passages of apatient.

In one embodiment of the present invention, a method for maintainingnasal passages open after nasal surgery, where the nasal passages areprone to obstruction by bodily fluids, is provided. In this embodiment,at least some of the bodily fluids are initially cleaned from the nasalpassages after the nasal surgery. A post-operative medical device havinga first tubular member and a second tubular member is provided, wherethe medical device is devoid of splints. The first tubular member has afirst proximal end and a first distal end, and the second tubular memberhas a second proximal end and a second distal end. The first proximalend is connected to the second proximal end with a bridging member. Thefirst distal end is inserted into a first nasal passage of a patient,and the second distal end is inserted into a second nasal passage of thepatient. In this embodiment, the tubular members are simultaneouslyinserted into the nasal passages of the patient. In other embodiments,the tubular members are sequentially inserted into the nasal passagesbefore the first and second proximal ends of the tubular members areconnected with a bridging member. Packing may then be placed at leastpartially around each tubular member within the first and second nasalpassages. In some embodiments, a suture is passed through apertures inthe bridging member to stitch the bridging member to the columella ofthe patient.

In certain embodiments of the method of the present invention, theinsertion of a tubular member into a nasal passage comprises insertingthe tubular member into the nasal passage until the distal end of thetubular member contacts the upper portion of the throat, and thenpulling the tubular member out of the nasal passage a small distance,such as a distance of about 1 to about 5 millimeters. Alternatively, ameasuring device may be used to determine the length of the nasal floorbefore the tubular member is inserted into the nasal passage. Thetubular member may then be trimmed at the distal end to the properlength, if necessary, and inserted into the nasal passage the properdistance. Graduations on the tubular member may facilitate this purpose.In certain embodiments, the tubular member protrudes from the nasalopening a small distance, such as about 1 to about 7 millimeters, about2 to about 6 millimeters, or about 3 to about 5 millimeters. Suchprotrusion facilitates the cleaning of the tubular member by thepatient.

The medical device may remain within the nasal passages of a patient forany suitable period of time. The device may remain within the nasalpassages until the nasal architecture is sufficiently healed to permitremoval of the packing material, as determined by the patient'sphysician. For example, the device may remain within the nasal passagesof a patient for a period of about one to about five days. In someembodiments of the method of the present invention, the device isremoved after about two days, three days, four days, or five days. Thedevice may be removed in any suitable manner, including withoutlimitation, by hand or by using an appropriate medical instrument.

In certain embodiments of the method of the present invention, such asthe embodiment illustrated in FIG. 7, a syringe 52 is used to clean eachtubular member 20 by using water or another suitable fluid 54 to flushany obstructing material through the tubular member 20. The cleaning maybe performed by either the patient or the physician by simply placingthe syringe at least partially into the tubular member and squeezing thesyringe 52 to release the fluid 54 and flush the obstructing materialfrom the tubular member 20. Any suitable type of syringe or othercleaning device may be used. For example, a suction device, an elongatedand flexible rod-like device adapted to be inserted into the tubularmember, or a syringe 52 with a flexible bulb portion 56 may be used. Thecleaning device may include an adapter to removably connect the cleaningdevice to each tubular member.

Any type of suitable packing material may used in this embodiment of themethod of the present invention. Examples of suitable packing materialsinclude, but are not limited to, polyvinyl alcohol expandable foampacking; petrolatum-impregnated gauze; absorbable, oxidized, regeneratedcellulose knitted fabric; absorbable, oxidized, regenerated cellulosepledgets; cotton wadding; and non-adherent pads. In embodiments wherenon-adherent pads are used, the pad may be folded along the longitudinalaxis of the pad before insertion of the pad into the nasal passage.Multiple pads may be used in this manner.

To assist with the placement of packing material into the nasal cavityof a patient to at least partially surround the tubular member of themedical device, a specialized speculum may be used. One embodiment ofsuch a speculum 60 is illustrated in FIG. 8. In this embodiment, thespeculum has a handle 68, a first leg member 64, and a second leg member62. The first leg member may have any shape suitable for insertion intothe nasal passage of a patient and for application of pressure againstthe inner wall of the nasal cavity to temporarily expand the nostrilopening 38, as shown in FIG. 8A, and increase the medical professional'svisual and spatial access to the area surrounding a tubular member of amedical device, with minimal discomfort to the patient. In oneembodiment, the first leg member 64 has a slightly curved or arc shapethat generally conforms to the curvature of the nostril of the patient,and the second leg member 62 includes a tube engaging member 66 adaptedto partially surround and/or mate with a tubular member 20 of apost-operative medical device. The tube engaging member 66 may beintegral with the second leg member 62 of the specialized speculum 60 orit may be added as a retrofit to a typical speculum to create aspecialized speculum.

In operation, as shown in FIG. 9, after insertion of a tubular member 20into the nasal passage of a patient following surgery, the specializedspeculum 60 may be inserted into the nasal passage in a first position.The speculum may then be moved to a second position that results in thetube engaging member 66 partially surrounding and mating with theexternal curvature of the tubular member 20 of the post-operativemedical device, thereby stabilizing the tubular member 20 and exertingsufficient pressure against the tubular member 20 to permit easyplacement of packing material 58 between the tubular member 20 and theinner wall of the nasal cavity 44 of the patient. The packing material58 may be inserted using forceps 70, as shown in FIG. 9, or any othersuitable instrument.

The specialized speculum 60 may be made from any suitable material forinsertion into the nasal passage of a patient. For example, thespecialized speculum 60 may be made from a suitable metal such as asterilizable stainless steel. Alternatively, the specialized speculummay be made from a less costly, single-use material such as a suitableplastic.

In some embodiments of the present invention, a kit is provided, wherethe kit includes a post-operative medical device and a specializedspeculum, such as the speculum described above. In certain embodiments,the specialized speculum is a single-use speculum. In some embodiments,the kit also may include other components useful following nasalsurgery, such as a suitable packing material.

The embodiments of the present invention may be useful for at least thesurgical specialties relating to head and neck (ear, nose, and throat)surgery and plastic surgery. Additionally, individuals practicing oralsurgery, a dental specialty whose sphere includes some nasal surgery,may avail themselves of the advantages of the present invention, as mayother medical professionals.

While the invention has been described with reference to particularembodiments, it will be understood by those skilled in the art thatvarious changes may be made and equivalents may be substituted forelements thereof without departing from the scope of the invention. Inaddition, many modifications may be made to adapt a particular situationor material to the teachings of the invention without departing from theessential scope thereof. Therefore, it is intended that the inventionnot be limited to the particular embodiment disclosed as the best modecontemplated for carrying out this invention, but that the inventionwill include all embodiments falling within the scope of the appendedclaims.

1. A method for maintaining nasal passages open after nasal surgery,wherein the nasal passages are prone to obstruction by bodily fluids,the method comprising: (a) initially cleaning at least some of thebodily fluids from the nasal passages after the nasal surgery; (b)providing a post-operative device comprising a first tubular membercomprising a first proximal end and a first distal end, and a secondtubular member comprising a second proximal end and a second distal end,wherein the first proximal end is connected to the second proximal endwith a bridging member, and the post-operative device is splintless; (c)inserting the first distal end and the second distal end into nostrilopenings and through the nasal passages to a location where the firstproximal end and the second proximal end each protrude beyond thenostril openings of a patient; and (d) positioning the first distal endand the second distal end at an entrance to a patient's throat.
 2. Themethod of claim 1 further comprising securing the bridging member to acolumella of a patient.
 3. The method of claim 2 wherein the bridgingmember is secured to the columella by suturing the bridging member tothe columella.
 4. The method of claim 3 wherein the bridging membercomprises an aperture and the bridging member is sutured to thecolumella by passing a suture through the aperture and the columella. 5.The method of claim 1 wherein the first proximal end is connected to thesecond proximal end after the first distal end and the second distal endare inserted into the nasal passages.
 6. The method of claim 1 whereinthe first proximal end is connected to the second proximal end beforethe first distal end and the second distal end are inserted into thenasal passages.
 7. The method of claim 1 wherein the method furthercomprising cleaning each tubular member with a syringe comprising afluid.
 8. The method of claim 7 wherein the step of cleaning eachtubular member with a syringe further comprises using an adapter toremovably connect the syringe to each tubular member.
 9. The method ofclaim 1 wherein each tubular member is slightly curved.
 10. The methodof claim 9 wherein each tubular member has an inner diameter of about 4millimeters and an outer diameter of about 6 millimeters.
 11. The methodof claim 1 further comprising removing the post-operative device fromthe nasal passages at least two days after insertion.
 12. The method ofclaim 1 further comprising using a speculum to facilitate at leastpartially surrounding each tubular member with packing material.
 13. Themethod of claim 1, further comprising at least partially surroundingeach tubular member with packing material so that the first distal endand the second distal end extend distal to the packing material in thenasal passages.
 14. The method of claim 13, comprising inserting thefirst distal end and the second distal end into the nasal passages untilthe first and second distal ends contact an upper portion of a patient'sthroat and withdrawing the first and second distal ends away fromcontact with the throat.
 15. The method of claim 14, comprisingwithdrawing the first and second distal ends about 1 to about 5 mm awayfrom the throat.
 16. The method of claim 1, further comprising insertinga cleaning device into an opening in the proximal end of the firsttubular member and flushing the first tubular member with a fluid. 17.The method of claim 1, comprising connecting the first tubular memberand the second tubular member with the bridging member so that thebridging member connects the first tubular member and second tubularmember without covering an opening in the first proximal end and anopening in the second proximal end.
 18. The method of claim 1, furthercomprising providing a medical device for holding the first tubularmember, the medical device having a first position and a second positionwithin the nasal passage.
 19. A method for maintaining nasal passagesopen after nasal surgery, wherein the nasal passages are prone toobstruction by bodily fluids, the method comprising: (a) initiallycleaning at least some of the bodily fluids from the nasal passagesafter the nasal surgery; (b) providing a post-operative devicecomprising a first tubular member comprising a first proximal end and afirst distal end, and a second tubular member comprising a secondproximal end and a second distal end, wherein the first proximal end isconnected to the second proximal end with a bridging member, and thepost-operative device is splintless; (c) inserting the first distal endand the second distal end into nostril openings and through the nasalpassages to a location where the first proximal end and the secondproximal end each protrude beyond a nostril opening of a patient; (d)positioning the first distal end and the second distal end at anentrance to a patient's throat; (e) securing the bridging member to thecolumella by suturing the bridging member to the columella; and (f)trimming the first distal end and the second distal end prior tosecuring the post-operative device.
 20. The method of claim 19, furthercomprising providing markings on the first and second tubular members todetermine an appropriate length of the first and second tubular members.